Sr. Director Regulatory Affairs North America

Thermo Fisher Scientific Inc. Needham , MA 02492

Posted 2 months ago

Job Description:

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

How will you make an impact?

As the Senior Director of Regulatory Affairs for North America, you will build and oversee the Regulatory Compliance and CMC services capabilities in North America covering chemical and biological Drug Substance and Drug Product (Clinical and Commercial) Contract Manufacturing and Development (CDMO) Services, including:

  • Monitoring and dissemination of US and ROW regulatory the Global network.

  • Interacting with PSG ( Pharma Services group) sites, sales, business management and clients to deliver Regulatory CMC services.

  • Ensuring site & product compliance to standards.

  • Establish and maintain external influence with key Health Authorities

  • Lead of NA Regulatory group in a matrix organization

Regulatory Intelligence

  • Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations for PSG

  • Collaborate with health authorities and key industry stakeholders as to provide input on new regulatory trends and provide SME consultation to organization

  • Sponsor internal regulatory knowledge by developing appropriate forums

  • Contribute to Corporate Quality Standards, Guidelines and Positions Papers and facilitate their implementation

Regulatory Services

  • Develop and implement the NA Regulatory CMC service offering

  • Ensure local regulatory capabilities by training, guiding and growing suitable tools to enable regulatory business opportunities and associated revenues generation

  • Contribute to key projects in the North American region such major tech transfers and new strategic customers

  • Assist within regulatory quotations issuance, lead or influence regulatory strategies

  • Deliver ad hoc expertise on registration files relevant to items such as IND, NDA, BLA, ANDA, NADA, PAS, CBE/30, AR, and assess overall regulatory risks

Regulatory Compliance Activities

  • Identify opportunities for harmonization & optimization, assist in work plan definition to fulfill the gaps and follow-up on implementation and maintenance at a site level

  • Site compliance: oversee domestic licenses, foreign accreditation, master documents, and contribute to official regulatory inspections and key customer audits

  • Product compliance: collaborate and contribute to critical activities such as regulatory systems, compliance programs and quality issue resolution

  • Develop and maintain relationship with key Health Authorities and regulatory organization

Lead NA Regulatory Organization

  • Establish goals and objectives for the NA regulatory organization

  • Within matrix environment support elements of human resource management, including hiring, on-boarding, performance management and development

  • Leverage talents and develop synergies across the NA Regulatory team to deliver the business strategy and goals

  • Use the Thermofisher PPI (Practical Process Improvement) system to create a culture of exceptional performance

How will you get here?

Education

Bachelors degree in Life Science (ex. Pharmacy, Engineering, Chemistry, Microbiology)

Experience

Minimum 12 years of directly relevant regulatory affairs, CMC, and cGMP manufacturing operational exposure

Knowledge, Skills, and Abilities

  • Intimate knowledge of global regulatory environment

  • Proven thought leadership within Biopharmaceutical manufacturing professional communities such as PDA, RAPS, DIA and PhRMA

  • Significant and demonstrated ability to successfully manage, lead, and build high performing teams

  • Must be able to sustain travel schedule of approximately 30%, both domestic and international

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.


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Sr. Director Regulatory Affairs North America

Thermo Fisher Scientific Inc.